New Work Item Proposal Harmonization of Good Clinical Practices IMDRF September 16, 2014
Background for ISO 14155 * – International standard – Good clinical practice for design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety or performance of medical devices for regulatory purposes. – General requirements • protect rights, safety and well-being of human subjects • ensure scientific conduct of clinical investigation/credibility of results • define responsibilities of sponsor and principal investigator, and assist sponsors, investigators, ethics committees *Does not apply to IVDs
Specific areas for harmonized approach • De finition of a “qualified” Independent Ethics Committee (IEC) or Institutional Review Board (IRB) Audits – potential MOUs among regulators • Need common Medical Device Clinical Trial Classification scheme • (e.g., Significant Risk/Non-Significant Risk ) Agreement that approval should not be denied if one or more • studies were not GCP-compliant unless data from the study(ies) essential for determination of safety & effectiveness/performance Ensure use of de-identified specimens critical to IVD development • as IVDs have unique considerations for good study practices guidance) Any harmonized agreement should be prospective and should allow • adequate transition timeframe.
Purpose for GCP harmonization • Ensure efficient, appropriate conduct of trials • Ensure regulator acceptance of clinical trial data conducted according to ISO 14155 independent of where trial was conducted • Reduce costs of clinical trials • Eliminate need to repeat trials • Fewer studies leads to more ethical conduct overall (i.e., need for less experimentation/fewer human subjects) • Allow faster introduction of safe and beneficial technologies for patients
New Working Group • Industry experts on working group essential • Other clinical experts as needed (e.g., ISO 14155 and academic representatives) • 18 months to complete work
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